Laboratory Safety of Dupilumab, and Its Effect on Inflammatory Biomarkers, in Chinese Adults with Moderate-to-Severe Atopic Dermatitis: An Analysis of a Randomized, Double-Blind Phase III Study

Abstract

Objective: Limited information is available on the use of dupilumab for the treatment of atopic dermatitis (AD) in the Chinese population. Methods: We analyzed laboratory data from a previously published randomized, double-blind phase III trial (NCT03912259) to provide further insight into the safety of dupilumab in Chinese adults with moderate to severe AD. The trial participants received either 300 mg of dupilumab or placebo every 2 weeks for 16 weeks. Hematology, blood chemistry, serum thymus and activation-regulated chemokine (TARC), and total immunoglobulin E (IgE) were evaluated. Results: In total, 82 participants received dupilumab and 83 received placebo. With the exception of eosinophil counts of >0.8 × 109/L, which were found less frequently with dupilumab (9.8%) than with placebo (18.7%), the hematology and blood chemistry values were generally stable in both treatment groups. There were no clinically significant differences between the dupilumab and placebo groups, and no participants developed treatment-emergent abnormalities of potential clinical significance. However, compared with placebo, greater decreases in serum lactate dehydrogenase (mean change, -97.4 vs. -33.5 IU/L), TARC (median percent change, -78.6% vs. -30.8%), and total IgE (median percent change, -53.4% vs. -0.2%) were observed with dupilumab than placebo at week 16. Conclusion: Dupilumab demonstrated a favorable laboratory safety profile in Chinese adults with moderate to severe AD.